Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
- To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
- To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (auto HSCT tbo-filgrastim) Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. |
Procedure: Hematopoietic Cell Transplantation
Undergo auto HSCT
Drug: Tbo-filgrastim
Given subcutaneously
Other Names:
Other: Laboratory Biomarker Analysis
Correlative Studies
|
| Experimental: Group II (auto HSCT) Patients undergo auto Hematopoietic Cell Transplantation (HSCT). |
Procedure: Hematopoietic Cell Transplantation
Undergo auto HSCT
Other: Laboratory Biomarker Analysis
Correlative Studies
|
Outcome Measures
Primary Outcome Measures
- Number of days to discharge [Up to 60 days]
Will compare days to discharge readiness between the two groups.
Secondary Outcome Measures
- Median days post autologous hematopoietic cell transplantation (auto HSCT) to neutrophil engraftment [Up to 60 days]
Will be defined as absolute neutrophil count > 500 x 10^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count > 500 x 10^9/L.
- Median days post auto HSCT to platelet engraftment [Up to 60 days]
Will be defined as date platelet greater than or equal to 20 x 10^9 /L without a platelet transfusion within the last 7 days.
- Incidence of engraftment syndrome [Up to 60 days]
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
- Median number of febrile days during the auto HSCT inpatient stay [Up to 60 days]
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
- Median number of days of febrile neutropenia during the auto HSCT inpatient stay [Up to 60 days]
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
- Median number of documented infections treatment during the auto HSCT inpatient stay [Up to 60 days]
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
- Median number of antibiotic days during the auto HSCT inpatient stay [Up to 60 days]
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
- Median number of days on corticosteroids [Up to 60 days]
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
- Number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT [Up to 60 days]
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Undergoing autologous stem cell transplant for one of the following diagnoses:
-
Multiple myeloma
-
Non-Hodgkin lymphoma
-
Karnofsky performance status of >= 70%
-
Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
-
Left ventricular ejection fraction (LVEF) of ≥ 40%
-
Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
-
Serum bilirubin < 1.8
-
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X upper limit of normal
-
Serum creatinine =< 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
-
Willingness to use contraception if childbearing potential
-
Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
-
Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
-
Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
-
Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis
Exclusion Criteria:
-
Uncontrolled human immunodeficiency virus (HIV)
-
Uncontrolled bacterial infection
-
Active central nervous system (CNS) disease
-
Pregnancy or lactation
-
Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
- Principal Investigator: Dolores Grosso, DNP, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17D.404